Instrumental and Non-Instrumental Perineal Message and Childbirth

NCT05190913 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-10-31

No results posted yet for this study

Summary

Today, the increase in the costs of applications in the health care system makes it difficult for easy and inexpensive methods to be used based on evidence. In this study, the episiotomy rate, episiotomy length, perineal pain at birth and postpartum period, perineal trauma, newborn 1st min. and 5 min. It was planned as a Randomized Controlled Experimental study to examine the effect of APGAR score on birth outcomes such as the duration of the first and second stages of labor and birth satisfaction.

The universe of the research was carried out between December 2021-2022 in University Hospital and City Hospital Pregnant women at 38-42 weeks of gestation who are admitted to the maternity ward to give birth. Power analysis was performed using the GPower program in order to sample size. In determining the sample size, the article titled "The Effect of Perineal Massage During Labor in Nulliparous Women on Birth Comfort, Perineal Pain and Trauma" (Yaşar, 2019) was used. Considering the total mean scores of the GCS scale in intervention and control groups, Type 1 error amount was 0.01, test power was 0.99, and effect size was 1.1276841; The minimum required sample size was determined as 80 (40 interventions + 40 control groups) for the intervention and control groups. In line with these data, it was decided that the sample size would be 120 pregnant women who agreed to be in the study and met the inclusion criteria, 40 in the intervention-1 group to be given instrumental perineal massage, 40 in the intervention-2 group that would receive non-instrumental perineal massage, and 40 in the control group.

Frequency and mean values will be used in the evaluation of descriptive data, and independent sample t-test, chi-square test, fisher chi-square test and ANOVA will be used in the analysis of data showing normal distribution. The Mann Whitney U test is planned to be used in the analysis of data that do not show normal distribution. Normal distribution in the analysis of the relationship between prenatal instrument perineal massage and GCS scores, quality of pain, length of episiotomy, condition of the perineal region, duration of the first and second stages of labor, total delivery time, APGAR 1st and 5th minute scores, and parameters related to postpartum satisfaction Pearson correlation test will be used. All the results will be evaluated at the 95% confidence interval, at the 0.05 significance level.

Conditions

  • Labor

Interventions

OTHER

Instrumental perineal massage

In the active phase of labor, perineal massage will be performed with an instrument twice with an interval of one hour.

OTHER

manual perineal massage

In the active phase of labor, manual perineal massage is performed twice an hour apart.

Sponsors & Collaborators

  • Namik Kemal University

    lead OTHER

Principal Investigators

  • Meryem Metinoğlu · TNKU

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-22
Primary Completion
2022-12-12
Completion
2023-07-13

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05190913 on ClinicalTrials.gov